Transcranial Direct Current Stimulation for Depression in Alzheimer's Disease Patient - Preliminary Research

NCT02351388 | Terminated DMC

• 1 other identifier: A2014-086
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This project will investigate the safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of depression among patients with Alzheimer's disease. The investigators aim to ameliorate depressive symptoms among patient with Alzheimer's disease, by anodal stimulation on left dorsolateral prefrontal cortex and cathodal suppression on right supraorbital area. Active stimulation will be compare to sham condition in 20 patients (10 in each groups).

Conditions

Alzheimer Disease; Depression

Keywords

Alzheimer's disease; Depressive symptoms; Neuropsychiatric symptoms; Behavioral and Psychological Symptoms of Dementia; Neuromodulation; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

• Attrition rate due to any adverse event

  three weeks

Secondary Outcomes (7)

• Rate of adverse events related to tDCS procedure

  three weeks

• Geriatric Depression Scale

  one week, two weeks, three weeks, five weeks (followup)

• Cornell Scale for Depression in Dementia

  two weeks, three weeks, five weeks (followup)

• Neuropsychiatric Inventory

  three weeks, five weeks (followup)

• Zarit Burden Interview

  three weeks, five weeks (followup)

Other Outcomes (3)

• Clinical Dementia Rating

  baseline

• Quality of Life - Alzheimer's Disease

  baseline

• ADCS-ADL

  baseline

Study Arms (2)

Active stimulation

ACTIVE COMPARATOR

Duration: 30 minutes Intensity: 2 mA Placement: left dorsolateral prefrontal cortex and right supraorbital area Size of electrodes: 5 cm x 7 cm Frequency: 5 days a week for three weeks

Device: Transcranial Direct Current Stimulation

Sham stimulation

SHAM COMPARATOR

Duration: 30 minutes Intensity: 2 mA Placement: left dorsolateral prefrontal cortex and right supraorbital area Size of electrodes: 5 cm x 7 cm Frequency: 5 days a week for three weeks

Other: Sham Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

Active stimulation

Sham Stimulation OTHER

Sham stimulation

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Participants who meets criteria of probable Alzheimer's disease defined by NINCDS-ADRDA research criteria.
• Participants who meets criteria of depression in Alzheimers defined by NIMH criteria.
• Participants who have been on fixed dose (including participants without any prescription) of antidepressants for at least two weeks on the screening visit.
• Participants who have been on fixed dose (including participants not prescribed) of antidementia drugs (donepezil, rivastigmine, galantamine, and memantine) for at least for weeks on the screening visit.
• Ambulatory participants with or without any aiding device
• Participants who have one caregiver, who must live with the patient at least ten hours a week and must report the patient's behavior.
• A study partner who can report how the participant is doing is needed.
• Eligible family member must sign and give consent on behalf of participants, whereas participants can give assent.

You may not qualify if:

• In case their cognitive deficits are better explained by another disease (e.g., cerebral infarction, Parkinson disease, multiple sclerosis, normotensive hydrocephalus).
• In case they have history of epilepsy
• In case they need treatment by antipsychotics due to significant psychotic symptoms
• In case they have urgent risk of suicide or severe depression and any doctor require their hospitalization to psychiatric units.
• In case they have history of ineffectiveness with electroconvulsive therapy (ECT) or transcranial direct current stimulation (tDCS)
• In case ECT or tDCS is clinically contraindicated
• In case they are taking benzodiazepines or antiepileptic drugs on the screening visit
• In case they scored less than ten on Mini Mental State Exam (MMSE) or scored 3 or more on Clinical Dementia Rating (CDR)
• In case his/her GDS score is lower than 6 at baseline
• In case he/she is unable to agree video recording on evaluation interview

Sponsors & Collaborators

• National Center of Neurology and Psychiatry, Japan: lead

Study Sites (1)

National Center of Neurology and Psychiatry

Kodaira, Tokyo, 187-8551, Japan

Location

Related Publications (1)

• Narita Z, Yokoi Y. Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial. Trials. 2017 Jun 19;18(1):285. doi: 10.1186/s13063-017-2019-z.

  PMID: 28629447 DERIVED

Related Links

• UMIN CTR database

MeSH Terms

Conditions

Alzheimer Disease; Depression; Behavior

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Yuma Yokoi, MD

  National Center of Neurology and Psychiatry, Japan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: January 30, 2015
• Study Start: December 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: March 15, 2018
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

JP (1)